Data / Medical devices / China / Shanghai Mekon Medical Devices Co., Ltd.
Shanghai Mekon Medical Devices Co., Ltd.: FDA-registered device maker in shanghai, China, 8 510(k) clearances
Shanghai Mekon Medical Devices Co., Ltd. is registered with the FDA (registration 3012552122) in shanghai, China. It lists 11 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012552122
- Address
- 526, No. 697-3 Lingshi Road Shanghai China, shanghai, China, 200072
- Owner or operator
- Shanghai Mekon Medical Devices Co., Ltd. (10059181)
- Roles
- Exporter to the US
- First device listed
- December 9, 2018
- Registered through
- 2026
- Brand names listed
- Blood Collecting Needles, Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles, Manual Vacuum-Assisted Blood Collection System, MiniLoad® Syringes, OcuJect Ophthalmic Needle Needle, OcuSafe® Needle;VitreJect® Safety Needle;Needle;LDS Needle, OcuSafe® Ophthalmic Needle; VitreJect® Ophthalmic Safety Needle; SteriCap® Safety Needle;, OcuSafe® Ophthalmic Needle; VitreJect® Safety Ophthalmic Needle; SteriCap® Safety Ophthalmic Needle; and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Exporter to the US | accessdata.fda.gov |
| Low Dead Space Needle, Single Lumen, Hypodermic | QNS | 2 | Exporter to the US | accessdata.fda.gov |
| Low Dead Space Piston Syringe | QNQ | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US | accessdata.fda.gov |
| Ophthalmic Needle | QYM | 2 | Exporter to the US | accessdata.fda.gov |
| Ophthalmic Syringe | QLY | 2 | Exporter to the US | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Exporter to the US | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Exporter to the US | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 25, 2024 | K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle | QNS | Substantially Equivalent | Ocuject, LLC | accessdata.fda.gov |
| September 29, 2023 | K220458 | UltraFlo-R Push Button Blood Collection Set | JKA | Substantially Equivalent | Innovative Medical Technologies, Inc. | accessdata.fda.gov |
| September 14, 2023 | K230959 | VitreJect® Needle; OcuSafe® Needle | FMI | Substantially Equivalent | Ocuject, LLC | accessdata.fda.gov |
| September 8, 2023 | K230372 | VitreJect Syringe | QLY | Substantially Equivalent | Ocuject, LLC | accessdata.fda.gov |
| October 13, 2021 | K212544 | MiniLoad Syringe | FMF | Substantially Equivalent | Ocuject, LLC | accessdata.fda.gov |
| June 4, 2018 | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder | JKA | Substantially Equivalent | Zhejiang Kindly Medical Devices Co., Ltd. | accessdata.fda.gov |
| January 5, 2018 | K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles | BSP | Substantially Equivalent | Zhejiang Kindly Medical Devices Co., Ltd. | accessdata.fda.gov |
| December 14, 2011 | K112057 | KDL SYRINGES AND NEEDLE | FMF | Substantially Equivalent | Shanghai Kindly Enterprise Dev. Group Co., | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Low Dead Space Needle, Single Lumen, Hypodermic
- All makers of Ophthalmic Needle
- All makers of Syringe, Piston
- All makers of Set, Administration, Intravascular
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
Updated October 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.